Gas Relief

Description

This product contains simethicone 180 mg as its active ingredient, classified as an antigas agent. It is formulated in a softgel dosage form, designed for fast relief of pressure, bloating, and discomfort associated with gas. The softgels are small and easy to swallow, enhancing patient compliance. This product is not manufactured or distributed by C.B. Fleet Company Inc., the distributor of Phazyme® Ultra Strength.

The product features a tamper-evident safety seal; it should not be used if the seal under the cap is broken or missing. For complete warnings and product information, the outer carton should be retained. It is distributed by Supervalu Inc., located in Eden Prairie, MN 55344, USA. Further details can be found at supervaluprivatebrands.com.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, or fullness commonly associated with gas. It provides fast relief of pressure, bloating, and discomfort.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should swallow one or two softgels as needed after a meal. The maximum recommended dosage is two softgels per day, unless otherwise directed by a physician. It is important for healthcare professionals to advise patients not to exceed this dosage without medical supervision.

Contraindications

There are no contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition persists.

Warnings and Precautions

Healthcare professionals should advise patients to consult with a health professional prior to use if they are pregnant or breastfeeding. This precaution is essential to ensure the safety of both the patient and the developing fetus or nursing infant.

It is imperative to keep the product out of reach of children to prevent accidental ingestion or misuse.

Patients should be instructed to discontinue use and seek medical advice if their condition persists. This recommendation is crucial for ensuring that any underlying issues are appropriately addressed and managed.

No specific emergency medical help instructions or laboratory tests have been provided; however, healthcare professionals should remain vigilant and assess the need for further intervention based on individual patient circumstances.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is important for individuals who are pregnant or breastfeeding to seek guidance from a health professional prior to using this product. Additionally, the product should be kept out of reach of children to ensure safety.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when administering this medication to children.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Stabilization: Ensure the airway is patent, breathing is adequate, and circulation is stable. Administer supplemental oxygen if necessary.

3. Decontamination: If the overdose is recent and the patient is alert, activated charcoal may be considered to limit further absorption of the substance.

4. Symptomatic Treatment: Address any specific symptoms that arise, such as administering intravenous fluids for hypotension or medications to manage seizures.

Healthcare professionals should also consult local poison control centers or toxicology experts for guidance on specific antidotes or additional interventions that may be appropriate based on the substance involved in the overdose.

Documentation of the incident and the management steps taken is crucial for ongoing patient care and for any necessary reporting to regulatory authorities.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand that if their condition persists despite using the medication, they should stop use and consult a doctor for further evaluation and guidance. This ensures that patients are aware of the need for professional medical advice in the event of ongoing symptoms.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 15º to 30ºC (59º to 86ºF). Care must be taken to protect the product from heat and moisture to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with patients instructed to swallow one or two softgels as needed after a meal. It is important for patients not to exceed a total of two softgels per day unless advised and supervised by a physician. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Gas Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)